What we publish on medicines and when

The European Medicines Agency (EMA) publishes information on human medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation.

EMA has published a guide to the different types of information stakeholders can expect on this website about centrally and non-centrally authorised medicines, including the publication times and location:

For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights to communicate information of major public interest, usually the day after their meetings have ended.

As a matter of good practice, marketing authorisation holders, applicants and third parties should wait until EMA communication is published before publishing their own communication related to the committee’s outcome.

After the European Commission decision, depending on the outcome of the re-examination, the same set of documents as for positive and negative opinions will also be published (see tables 2 and 3 above).

Re-examinations After the European Commission (EC) decision, depending on the outcome of the re-examination, the same set of documents as for positive or negative opinions on extension of indication will be published.